Clinical Trial: Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective, Randomized, Controlled, Blinded, Comparative Study of Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plant
Brief Summary: This is a prospective, controlled, randomized, blinded and comparative, single-center clinical trial comparing the improvement of patients with recalcitrant plantar fasciitis symptoms that have received standard of care versus treatment with differing amounts of injectable dehydrated human amnion/chorion membrane micrografts(dHACM).
Detailed Summary:
Sponsor: MiMedx Group, Inc.
Current Primary Outcome: Reduction of inflammation as measured by AOFAS Hindfoot scores [ Time Frame: 8 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Return to normal activities more quickly than with standard of care [ Time Frame: 8 Weeks ]The secondary objective is to demonstrate that patients treated with micronized dHACM injectable will return to normal activities more quickly than with standard of care.
- Pain as measured by 0-10 Numeric Rating Scale [ Time Frame: 12 weeks ]Patient pain scores will be assessed between all groups.
Original Secondary Outcome: Same as current
Information By: MiMedx Group, Inc.
Dates:
Date Received: October 10, 2013
Date Started: September 2013
Date Completion:
Last Updated: June 12, 2014
Last Verified: June 2014